Univasc News

Univasc Q&A

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, univasc® should be discontinued as soon as possible. See Warnings, Fetal/Neonatal Morbidity and Mortality.

UNIVASC SUMMARY

univasc® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C27H34N2O7 ·HCl and a molecular weight of 535.
It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat.

univasc® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics.

In using univasc®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc® does not have a similar risk (see WARNINGS).

In considering use of univasc®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).

NEWS HIGHLIGHTS

Published Studies Related to Univasc (Moexipril)

Moexipril shows a long duration of action related to an extended pharmacokinetic half-life and prolonged ACE inhibition. [2002.01]OBJECTIVE: To characterize the lipophilic ACE inhibitor moexipril and its active metabolite moexiprilat regarding the duration of action, the susceptibility of the pharmacokinetics and pharmacodynamics to food intake and the concentration-dependent effect... CONCLUSION: Moexiprilat showed an extended duration of action owing to a long terminal pharmacokinetic half-life and produced a persistent ACE inhibition. Although the pharmacokinetics were partly influenced by food intake, ACE inhibition was not affected. This might be explained by a second compartment directly related to the ACE which is less prone to food effects and the reaching of a ceiling in the sigmoidal concentration-effect curve even with the lower Cmax concentrations associated with the postprandial state.

Clinical Trials Related to Univasc (Moexipril)

Moexipril for Primary Biliary Cirrhosis [Completed]
The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different
experimental models of chronic liver injury. We aimed to determine the safety and efficacy of
moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo
risk score, and health-related quality of life in patients with primary biliary cirrhosis
(PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).

Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery [Not yet recruiting]
Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and
including the morning of an intermediate risk surgery will experience more intraoperative
hypotension than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and
including the morning of an intermediate risk surgery will experience better postoperative
control of hypertension than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and
including the morning of an intermediate risk surgery will experience less acute renal
failure than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #3: Patients with a preoperative systolic blood pressure less
than 110 mmHg who are continued on their chronicACEI therapy perioperatively will have a
significant decrease in blood pressure during anesthesia compared to those who have a
preoperative systolic blood pressure greater than 110 who are continued on their chronic
ACEI.
Secondary research hypothesis #4: Patients above the age of 64 who are continued on their
chronic ACEI therapy perioperatively will have a significant decrease in blood pressure
during anesthesia compared to those aged 64 or younger who are continued on their chronic
ACEI.

1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure
control in patients with untreated hypertension as well as in patients with treatment
refractory or resistant hypertension that are managed by Clinical Hypertension
Specialists.

2. Renin-guided therapeutics will reduce the number of medications required to maintain
blood pressure control to <140/90 mmHg in hypertensive patients receiving 3 or more
medications, while under the care of a Clinical Hypertension Specialist.